Kobold® Prostate HDR Template - 18 ga

Primary DI
00815568021240
Brand
Kobold® Prostate HDR Template - 18 ga
Company
KOBOLD, LLC
Model
804-000
Device description
Labelled with CE
Published
2019-11-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JAQSystem, Applicator, Radionuclide, Remote-Controlled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAQSystem, Applicator, Radionuclide, Remote-ControlledRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170203000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170203000System, Applicator, Radionuclide, Remote ControlledKobold, LLC2017-06-01JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815568021240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815568021240008155680212408155680212400815568021240

GMDN Terms#

Term, Definition table
TermDefinition
Nonimplantable needle guide, single-useA rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
014292258
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815568021226Kobold® Prostate HDR Stepper Template - 17 ga/4 Fr812-0002019-11-20
00815568021233Kobold® Prostate HDR Stepper Template - 16 ga/5 Fr811-0002019-11-20
00815568021257Kobold® Prostate HDR Template - 17 ga/4 Fr803-0002019-11-20
00815568021264Kobold® Prostate HDR Template - 16 ga/5 Fr802-0002019-11-20
00815568020892Kobold® Prostate HDR Stepper Template - 6 Fr813-0002019-12-09
00815568020090Kobold® Prostate HDR Template - 16 ga/5 Fr802-0002017-07-18
00815568020106Kobold® Prostate HDR Template - 17 ga/4 Fr803-0002017-07-18
00815568020113Kobold® Prostate HDR Template - 18 ga804-0002017-07-18
00815568020137Kobold® Prostate HDR Stepper Template - 16 ga/5 Fr811-0002017-07-18
00815568020144Kobold® Prostate HDR Stepper Template - 17 ga/4 Fr812-0002017-07-19
00815568020922Kobold® Henschke-model Tandem and Ovoid Applicator Set (E)704-0002019-03-25
00815568020977Kobold® Fletcher-model Tandem and Barrel Ovoid Applicator Set (E)708-0012019-03-25
00815568020984Kobold® Fletcher-model Tandem and Cylinder Ovoid Applicator Set (E)708-0022019-03-25
00815568020991Kobold® Vaginal Cylinder Applicator Set (E)715-0002019-03-25
00815568020007Kobold® Henschke-model Tandem and Ovoid Applicator Set (E)704-0002016-09-23
00815568020014Kobold® Fletcher-model Tandem and Barrel Ovoid Applicator Set (E)708-0012016-09-23
00815568020021Kobold® Fletcher-model Tandem and Cylinder Ovoid Applicator Set (E)708-0022016-09-23
00815568020076Kobold® Vaginal Cylinder Applicator Set (E)715-0002016-09-23
00815568020151Kobold® Prone Breast Board325-0002016-09-23
00815568020168Kobold® Prone Belly Board315-0002016-09-23

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